Gambro WRO 300 User manual

WRO 300 H
HCEN12481-02/2012
Contact information
(To be filled in by the hospital/clinic)
If you need assistance in setting up, using or maintaining the
WRO 300 H; or if you want to report unexpected operation or
events, please refer to:
Postal address:
Phone number and/or web contact address:

WRO 300 H
Contact information HCEN12481-02/2012
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WRO 300 H
HCEN12481-02/2012 Preface
Preface
This manual provides the information needed to operate the
WRO 300 H water purification unit.
Other manuals for WRO 300 H
The list below shows all manuals related to this Operator’s
Manual.
Definitions of expressions in the manual
Valid program version 5.x
Service Manual WRO 300 / WRO 300 H, HCEN12482
Installation Guide WRO 300 / WRO 300 H, HCEN12479
WARNING
A warning alerts the reader about a situation which, if not avoided,
could result in an adverse reaction, injury or death.
CAUTION
The term caution is used for the statement of a hazard alert that
warns the reader of a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user or patient
or damage to the equipment or other property.
NOTE
Notes are added to give more information.

WRO 300 H
Preface HCEN12481-02/2012
Safety considerations
WARNING
Do not modify this equipment without a written authorization from the
manufacturer. Unauthorized installation, modifications, alterations or
repair of the WRO 300 H may result in malfunctioning or have other
serious consequences for the safe operation of the equipment and
will void the certification marks (e.g CE, CSA (C-US)).
WARNING
Dialysis machines that are supplied with water from the WRO 300 H
water purification unit must comply with IEC 60601-2-16.
WARNING
To avoid strangulation, ensure that cables and hoses have the proper
length; all loose cords are bundled and are neatly routed.
CAUTION
• WRO 300 H may be operated only by persons who have studied the
instructions in this manual and the manual for the dialysis monitor. If the
system does not perform as described in this manuals, it should not be
used until the condition is rectified.
• The operator should pay attention to alarms and follow the instructions,
warnings, cautions and notes given in the manual.
• The WRO 300 H will perform as designed only if it is used and maintained
in accordance with Gambro´s written instructions. Any warranties made
by Gambro with respect to the WRO 300 H are voided if the equipment is
not used in accordance with the written instructions provided. Gambro will
not accept responsibility for any damage or injury resulting from improper
use or maintenance or unauthorized repair.
• The use of mobile telephones or communication equipment in the vicinity
of the WRO 300 H could adversely influence the performance of the
machine. See specification.
• The WRO 300 H is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
• WRO 300 H needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided
in the Operator’s and Service manual.

WRO 300 H
HCEN12481-02/2012 5
NOTE
• During transportation and storage the equipment must be kept in its
original packing.
• For the qualified technician the WRO 300 / WRO 300 H Service Manual
is available. The Service Manual provides all of the necessary informa-
tion for the safe and required maintenance of the machine.
• The WRO 300 H is intended for continuous operation.

WRO 300 H
6HCEN12481-02/2012
Symbols fixed on the device or its packing
All symbols in the list below may not be represented on this product. The sym-
bols can be attached to the machine or attached to the original packaging.
Alternating current
Protective earth (ground)
Consult accompanying documents
Follow instructions for use
Off (power, disconnection from the mains)
On (power, connection to the mains)
Type B, applied part. According to IEC 60601-1: “Part of
ME EQUIPMENT that in NORMAL USE necessarily
comes into physical contact with the PATIENT for ME
EQUIPMENT or an ME SYSTEM to perform its function”.
For WRO 300 H, the applied part is the product water.
Handle with care
This way up
Keep dry

WRO 300 H
HCEN12481-02/2012 7
Separate collection for electrical and electronic
equipment
Input /Output
Manufacturer. Year of manufacturing
Year of manufacturing
The WRO 300 H is protected against solid foreign objects
≥12.5 mm Ø and vertically falling water drops
This symbol indicates that the water purification unit
WRO 300 H contains toxic or hazardous substances or
elements.
The figure 25 indicates the corresponding
environmental protection use period of the water
purification unit WRO 300 H.
(Valid for Main land China only)
Recycling symbol - General
Reject water connection
Feed water inlet connection and pressure limitation
Loop connections (Product water outlet and return)
IP21
25
CB

WRO 300 H
8HCEN12481-02/2012
Stacking limit by number (n = 3)
Temperature limit
Humidity limitation
Atmospheric pressure limitation
No pushing, risk for overbalance
No sitting, risk for overbalance
Serial number
Catalogue number
n

WRO 300 H
HCEN12481-02/2012 9
Certification marks
IPR - Intellectual Property Rights
The CE-conformity mark indicates that the WRO 300 H
water purification unit conforms to the requirements in the
EC Council Directive 93/42/EEC of 14 June, 1993 con-
cerning medical devices. It also indicates that the notified
body British Standards Institution (BSI, No. 0086) has
approved the Quality Management System. The CE con-
formity mark is only valid for the WRO 300 H water purifi-
cation unit. Disposables and any accessories specified
for use with the WRO 300 H water purification unit are
marked with CE conformity marks in their own right.
The CSA (C-US) mark indicates that the WRO 300 H
water purification unit conforms to the requirements
related to safety of medical devices for the US and
Canada. The "C" and the "US" adjacent to the CSA mark
indicates that the WRO 300 H water purification unit has
been evaluated to the applicable ANSI/UL and CSA
standards for use in the US and Canada.
Copyright
© 2005, 2007, 2010, 2012 Gambro Lundia AB
Trademarks
Gambro is a trademark of the Gambro Group.
Dialox is a trademark of L'Air Liquide.
Minncare and Minnclean are trademarks of Minntech.
SteriChek is a trademark of Hach Company.
Ultrasil is a trademark of Ecolab.
Memstor is a trademark of Axeon Water Technologies.

WRO 300 H
10 HCEN12481-02/2012
Manufacturer
Gambro Lundia AB
Box 10101
Magistratsvägen 16
SE-220 10 LUND
Sweden.
Phone [phone].
Fax [phone]
www.gambro.com

WRO 300 H
HCEN12481-02/2012 Content
Content
1 Introduction..................................................................... 13
1.1 Intended use .................................................................... 13
1.2 General ........................................................................... 14
1.2.1 Signal types ............................................................. 15
1.2.2 Conductivity monitoring ........................................... 16
1.2.3 Mains power switch ................................................. 18
1.2.4 Fuses ...................................................................... 18
1.3 Operator’s panel .............................................................. 19
1.3.1 Description of buttons .............................................. 19
1.3.2 Description of indications ......................................... 20
1.3.3 Reminders ............................................................... 21
1.3.4 Operational data....................................................... 22
2 Operation ........................................................................ 23
2.1 Start ................................................................................. 23
2.2 Stop ................................................................................. 23
3 Regular maintenance .................................................. 25
3.1 Heat disinfection and Low Flow Heat ............................ 25
3.1.1 Heat disinfection ...................................................... 26
3.1.2 Low Flow Heat ........................................................ 27
3.2 Chemical disinfection ..................................................... 28
3.2.1 Chemical disinfectants recommended by Gambro ....... 28
3.2.2 Chemical disinfection procedure................................ 29
3.2.3 Residual test after Chemical disinfection .................... 33
3.2.4 Central Chem........................................................... 34
3.3 Cleaning .......................................................................... 35
3.3.1 Warm Acid cleaning................................................. 35
3.3.2 Acid Cleaning agents recommended by Gambro ......... 35
3.3.3 Alkaline cleaning ..................................................... 36
3.3.4 Alkaline Cleaning agents recommended by Gambro.... 36
3.3.5 Cleaning procedure .................................................. 37
3.4 Long time Storage ........................................................... 38
3.4.1 Preservation............................................................. 38
3.4.2 Rinse after preservation ............................................ 39

WRO 300 H
Content HCEN12481-02/2012
3.4.3 Check for complete rinse-out..................................... 39
3.5 Flush ............................................................................... 40
3.5.1 Manual Flush ........................................................... 40
3.5.2 Auto flush................................................................ 40
3.6 Exterior cleaning ............................................................. 40
4 Technical data ............................................................... 41
4.1 Performance and specification ........................................ 41
4.2 Chemical disinfection and Cleaning ...............................47
4.3 Physical data ................................................................... 48
4.3.1 Materials in contact with product water ...................... 48
4.4 Environmental data ......................................................... 49
4.4.1 Electromagnetic environment .................................... 49
4.5 Safety .............................................................................. 55
4.6 Others .............................................................................. 55
5 Troubleshooting.............................................................57
5.1 Low priority alarms and information signals .................. 57
5.1.1 Audible alarm signal sound pressure .......................... 57
5.1.2 General ................................................................... 58
5.1.3 Operation ................................................................ 60
5.1.4 Heat and Low Flow Heat .......................................... 63
5.1.5 Chemical, Cleaning, Rinse and Preservation ............... 65
5.1.6 Perform residual test................................................. 69
5.1.7 Reminders ............................................................... 69
5.1.8 Start up error............................................................ 70
6 Check list......................................................................... 71
Index..................................................................................... 73

WRO 300 H
HCEN12481-02/2012 Introduction 13
1 Introduction
1.1 Intended use
The WRO 300 H (including the loop), is designed to be used as
a dialysis accessory device to produce product water by using
the reverse osmosis concept. The device can be used in conjunc-
tion with one dialysis machine provided that the input flow and
pressure demands correspond to the output of the device and
that it complies with IEC 60601-2-16. The device is intended
for hospital, clinic and home use.
CAUTION
The water produced by WRO 300 H should be analysed at installation
and on a regular basis to verify that it conforms to applicable regula-
tions or standards for water for dialysis.

WRO 300 H
14 Introduction HCEN12481-02/2012
1.2 General
The WRO 300 H has been designed to fulfil the special require-
ments of dialysis setting. For this purpose this device has the
following features:
• Simple user interface
• Automated Heat disinfection
• Chemical disinfection and cleaning modes
• Auto flush function during Standby periods to minimize
stagnant water.
This manual for WRO 300 H includes instructions for opera-
ting, monitoring, cleaning, disinfecting and troubleshooting this
device from an operator’s perspective. For installation instruc-
tions refer to separate Installation Guide.

WRO 300 H
HCEN12481-02/2012 Introduction 15
1.2.1 Signal types
All signals belong to one of the two types Low priority alarm
and Information signal. For details about specific low priority
alarms and information signals, refer to“Low priority alarms
and information signals” on page 57.
Low priority alarm
When a low priority alarm is issued, the yellow LED next to
is lit, and the signal (high, low) sounds.
Information signal
When an information signal is issued, the blue LED next to
is lit, and the signal (high) sounds.

WRO 300 H
16 Introduction HCEN12481-02/2012
1.2.2 Conductivity monitoring
The conductivity monitoring system in the WRO 300 H has
three limits, allowing for individual adaptation of alarm settings
to local preferences and regulations. The three limits are
described in the sections below.
All three limits are set to 60 µS/cm from factory. With this set-
ting the WRO 300 H will stop without any previous warning if
the product water conductivity exceeds this value.
Conductivity notification
Indicates that the product water conductivity is above normal
reading. It will be issued when the WRO 300 H enters Standby
mode if the notification limit has been exceeded for more than
30 consecutive seconds during the previous run period. It may
be caused by several reasons such as incipient fouling, degrada-
tion of the RO membrane or change in the feed water quality.
Conductivity alarm
The clinic's predefined maximum product water conductivity
for water for dialysis has been exceeded for more than 30 con-
secutive seconds. An audible and visual alarm will be issued.
The WRO 300 H will, however, continue in operation to allow
for finishing the dialysis treatment. The buzzer can be muted
indefinitely by pressing , however, the button remains lit to
indicate that the alarm persists.
NOTE
If the notification, alarm and stop limits are set to the same value the
priority of the action are in the order of stop, alarm and notification.
NOTE
If the feed water conductivity is known to vary significantly, the con-
ductivity notification limit should be inactivated by setting it at the
same value as the conductivity alarm, see below.

WRO 300 H
HCEN12481-02/2012 Introduction 17
Conductivity stop
The clinic's predefined maximum permissible product water
conductivity has been exceeded for more than 30 consecutive
seconds. An audible and visual alarm will be issued and
WRO 300 H will stop. The alarm can be acknowledged by
pressing . The WRO 300 H can be restarted, but the alarm
will reappear and the WRO 300 H will stop after 30 seconds if
the conductivity remains over the limit.
Setting of conductivity limits
• If the intention is to have an early warning of a change in the
product water conductivity, set the notification limit at a
value between the normal product water reading and the set
alarm limit.
• If the intention is to stop operation in case of a conductivity
alarm, set alarm and stop limits to the same value.
• If, in case of a conductivity alarm, the intention is to allow
for continued dialysis in order to finish the ongoing dialysis
treatment, set the alarm limit at the desired limit. The stop
limit at which the WRO 300 H will stop then has to be set at
a higher value.
To adjust the limits, refer to the Service Manual.
Low rejection rate notification
The rejection rate is the reduction (in %) of the conductivity of
the water in a reverse osmosis system. It depends on a number
of factors such as conductivity, pH and temperature of the feed
water and may vary significantly from one location to the other.
It should therefore not be considered as an absolute measure of
the quality of the water but rather as an indicator that can help
to detect changes in performance of the WRO 300 H which may
be caused by incipient fouling or degradation of the RO-mem-
brane.

WRO 300 H
18 Introduction HCEN12481-02/2012
The Low rejection rate notification default setting of 90 % is
relevant for most inlet water supplies. It may, however, need to
be adjusted at installation to a lower value by a qualified techni-
cian to fit local conditions, especially in cases of low feed water
conductivity (<100 µS/cm). The limit should be set at least 5 %
lower than the initial value recorded at installation.
The Low rejection rate notification will be displayed when the
WRO 300 H enters Standby if the set limit has been exceeded
for more than 5 consecutive minutes during the previous run
period.
1.2.3 Mains power switch
The mains power switch is only used in service situations to turn
off the power. The mains power switch is located on the rear
side behind a detachable cover.
Fig.1.1 Mains power switch and fuses
1.2.4 Fuses
The fuses F1 and F2 (T10A250V or T15A125V) are located as
depicted in Fig.1.1“Mains power switch and fuses” on page 18.
CAUTION
Make sure not to position the WRO 300 H in a way that it becomes
difficult to operate the mains power switch.
Mains power switch
F1
F2

WRO 300 H
HCEN12481-02/2012 Introduction 19
1.3 Operator’s panel
1.3.1 Description of buttons
Buttons Description
Press to start operation (RUN).
Press to stop operation (STANDBY).
Press to stop Heat disinfection procedure and Low Flow Heat.
Press to enter SELECT (only in Standby mode).
Press to start the selected procedure (SELECT or CHEM SELECT).
Press during the chemical intake procedure to pause.
Press during dwell period to initiate rinse.
Press to silence the audible alarm/information signal (AUDIO
OFF).
Press to reactivate the silenced audible alarm/information signal
Used to scroll and view data in the display.
Press any of the arrow buttons to unlock the display and enter the
alarm list.
Pressing both arrow buttons simultaneously will lock current infor-
mation in the display. Press any arrow buttons to release the
locking function.

WRO 300 H
20 Introduction HCEN12481-02/2012
1.3.2 Description of indications
Indications Description
Green Steady light Indicates that the WRO 300 H is ener-
gized.
Green
Steady light RUN mode, Auto flush or Manual Flush in
progress.
Slow flash
The Auto flush function and/or automated
Run by Time channels are activated. (only
in STANDBY mode).
Orange
Steady light Chemical disinfection, Heat disinfection,
Low Flow Heat or Cleaning is in progress.
Slow flash
The automated Heat disinfection by time
channels is activated. (only in Standby
mode).
Medium
flash
The disinfection wand connector is
inserted into the chemical intake.
During selection of procedure in SELECT
or CHEM SELECT.
The chemical intake phase is paused
Forced rinse is required (404 RINSE
REQUIRED).
Blue
Medium
flash
The audible alarm/information signal has
not been silenced.
Steady light The audible alarm/information signal has
been silenced.
Yellow Steady light Indicates a low priority alarm.
Blue Steady light Indicates an information signal.